Adagene Inc. announced on February 27, 2025, the initiation of an investigator-initiated (IIT) Phase 2 neoadjuvant trial for muzastotug (ADG126) in patients with stage II or stage III colorectal cancer. This new study (NCT06846268) is expected to begin patient enrollment in April 2025, with a primary completion target in mid-2027. Patients in the trial will receive high doses of ADG126 in combination with KEYTRUDA® prior to surgery.
The primary endpoint for this trial is the rate of Major Pathologic Response (MPR), defined as 10% or less residual viable tumor in the surgical specimen, and will be evaluated in up to 20 patients. Secondary endpoints include complete pathological response, disease-free survival, and safety/tolerability. This expansion into the neoadjuvant setting is supported by the compelling combination efficacy and safety profile observed with ADG126 and pembrolizumab in late-stage MSS CRC patients.
Advancing immunotherapy into the curative neoadjuvant setting holds significant promise for patients, potentially offering long-term clinical benefits by restoring anti-tumor immunity. This trial aims to further elucidate ADG126's unique mechanism of action and enhanced therapeutic index by exploring its pharmacodynamic effects on the tumor microenvironment's immune profile and its pharmacokinetic profile in tumor tissues.
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